Bristol-Myers Squibb Company and Kosan Biosciences Inc v. David Kappos

January 27, 2012

BRISTOL-MYERS SQUIBB COMPANY AND KOSAN BIOSCIENCES INC., PLAINTIFFS,v.DAVID KAPPOS, IN HIS OFFICIAL CAPACITY AS UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, DEFENDANT.

The opinion of the court was delivered by: Emmet G. Sullivan United States District Court Judge

MEMORANDUM OPINION

Plaintiffs Bristol-Myers Squibb Company and Kosan Biosciences Inc. filed this action on June 17, 2009 seeking review of certain patent term adjustments granted by the Director of the United States Patent and Trademark Office ("PTO"). Plaintiffs alleged that all of the challenged PTO patent term adjustment determinations relied on an erroneous interpretation of 35 U.S.C. § 154(b) rejected by the United States Court of Appeals for the Federal Circuit in Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010). The Amended Complaint identified twenty-one patents, set forth in twenty-one separate counts, for which the PTO allegedly incorrectly determined the patent term adjustment.

Of the twenty-one patents identified by plaintiffs in this action, the Court has already ordered thirteen remanded to the PTO for recalculation and adjustment of the disputed patent term in accordance with Wyeth. Court's Minute Order of June 23, 2010.*fn1 The eight Counts remaining are Count Five, Count Six, Count Eleven, Count Thirteen, Count Seventeen, Count Eighteen, Count Nineteen, and Count Twenty.

In addition, Civil Action Number 09-2420, Bristol-Myers Squibb Company v. Kappos, has been consolidated with this action. One remaining Count is pending therein, namely Count Four (United States Patent No. 7,514,430).*fn2

Defendant has filed a motion to dismiss the remaining claims, arguing that the plaintiffs failed to comply with 35 U.S.C. § 154(b)(4)(A), which requires an applicant dissatisfied with a patent term adjustment determination made by the PTO to file its appeal with the District Court "within 180 days after the grant of the patent." 35 U.S.C. § 154(b)(4)(A). Defendant asserts that all remaining counts should therefore be dismissed as untimely. Plaintiffs filed a cross-motion for summary judgment, asserting that the action is timely filed and that the disputed patent term adjustments should be remanded to the PTO for recalculation.

The parties agree that the sole legal question remaining in these cases is the timeliness of plaintiffs' appeals. For the reasons stated below, the Court finds that plaintiffs' appeals were timely filed. Accordingly, the Court hereby DENIES defendant's motion to dismiss and GRANTS plaintiffs' cross-motion for summary judgment. The remaining claims are hereby REMANDED to the PTO for recalculation and adjustment of the disputed patent terms in accordance with Wyeth v. Kappos, 591 F.3d 1364.

I.BACKGROUND

Patents are ordinarily granted "for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States." 35 U.S.C. § 154(a)(2). However, under 35 U.S.C. § 154(b)(1), a patent's term may be extended if the PTO causes certain delays in the process or if the patent takes longer than three years to issue.*fn3

After a patent application is filed, and "[i]f it appears that applicant is entitled to a patent under the law," the PTO issues a "written notice of allowance of the application."

Id. § 151. The notice of allowance specifies an issue fee that the applicant must pay within three months. Id. The PTO is required to make a determination of the period of any patent term adjustment and "transmit a notice of that determination with the written notice of allowance." Id. § 154(b)(3)(B)(i). The term of the patent, issued after the applicant pays the issue fee, will include any patent term adjustment determined by the PTO. If an applicant disagrees with the patent term adjustment determined by the PTO, the statute provides that the applicant is entitled to "request reconsideration of any patent term adjustment determination made by the Director." Id. § 154(b)(3)(B)(ii).

Furthermore, the statute permits the applicant to appeal the patent term adjustment to a United States District Court. Specifically, the statute provides:

An applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy by a civil action against the Director filed in the United States District Court for the Eastern District of Virginia within 180 days after the grant of the patent. Chapter 7 of title 5, shall apply to such action. Any final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change. Id. § 154(b)(4)(A).*fn4

In the instant case, the material facts are not in dispute. Plaintiffs did not file their appeals with this Court until more than 180 days after each of the remaining disputed patents had been issued.*fn5 However, with respect to each of the disputed patents, plaintiffs filed a request for reconsideration of the patent term adjustment under 35 U.S.C. § 154(b)(3)(B)(ii) and 37 C.F.R. § 1.705(d) within the requisite two month time period after the patent was granted. The sole question pending before this Court is whether the timely ...

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